When Can a Pharmacy Compound?

What is compounding?

A compound is a custom medication created by the pharmacist from base ingredients for a patient.

What are the benefits to compounding?

Dose can be adjusted or customized instead of choosing the closest commercially available dose. Can create the perfect dose for a patient based on their needs, height, weight, gender, age, etc. This may reduce side effects while getting the most efficacious dose.

Commercially available medications may be made into a different dose form. Different dose forms may include tablets, capsules, ointments, creams, lozenges, oral liquid, powder, etc. Changing the dose form or route may reduce side effects or improve compliance.

May be able to create more palatable dose forms for young children and pets!

When may a pharmacy compound?

•The quantity being prepared is reasonable for filling existing prescriptions or anticipated prescriptions based on prescribing habits of local prescribers and/or prescriptions already on file

•The compounded products are not being sold to other pharmacies or third parties like a physician’s office

•The compounded product is not a compounded version of an FDA-approved drug. An exception is made if there is a shortage or no supply of a commercially available product and there is a medical need for the product. 

•The ingredients used meet the official standards found in USP/NP, are a component of an already FDA-approved drug or are on a list of approved substances developed by the Secretary of the U.S. Department of Health and Human Services

•The pharmacy does not actively promote or advertise their compounding capabilities to solicit business  

•The pharmacy does not compound a drug that has been withdrawn or removed from the market because they were unsafe or ineffective

•The pharmacy limits their interstate distribution of compounded products to not more than 5% of the total prescriptions filled at the pharmacy

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